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J Thorac Cardiovasc Surg 1994;107:472-0481
© 1994 Mosby, Inc.
Cardiac and Pulmonary Transplantation |
St. Louis, Mo.
Address for reprints: D. Glenn Pennington, MD, Department of Surgery, 3635 Vista Ave. at Grand Blvd., P.O. Box 15250, St. Louis, MO 63110-0250.
Abstract
Although bridging to cardiac transplantation has become a therapeutic option for transplant candidates whose condition deteriorates while they are awaiting a donor heart, short-term efficacy has not been proved and long-term survival has not been reported. We retrospectively reviewed data on 44 patients who had circulatory assist devices placed as a bridge to transplantation between May 1985 and April 1993. The 35 male and nine female patients ranged in age from 12 to 65 years (mean 43.8 years). Thirty-one patients were supported with 32 Thoratec (18 left ventricular, 14 biventricular), 11 Novacor, and two Jarvik J-7-70 devices. The duration of device support was from 4 hours to 440 days (mean 45.5 days). Fifteen patients did not receive a donor organ because of infection (ten patients), renal failure (five patients), bleeding (nine patients), cerebrovascular accident (three patients), ventricular fibrillation (one patient), and right heart failure (one patient), and all died. Two patients were weaned from support and survived without transplantation. Twenty-seven patients underwent transplantation, and 26 survived (96%). Overall survival was 64% (28/44). Duration of survival ranged from 2 to 96 months (mean 35 months). Among the 28 hospital survivors, there were four late deaths (all transplant recipients) at 3, 6, 14, and 68 months. Posttransplantation actuarial survivals at 1, 5, and 8 years are 88%, 83%, and 66%. Twenty-three of the 24 patients presently alive are in New York Heart Association functional class I. These data demonstrate the short- and long-term efficacy of bridging to transplantation with circulatory support devices. The excellent survival and full functional recovery of patients undergoing transplantation ensure that donor organs are not being "wasted" on the sickest patients. (J THORAC CARDIOVASC SURG 1994;107:472-81)
Recent estimates indicate that 30,000 to 60,000 patients in the United States each year are candidates for heart transplantation or permanent mechanical circulatory support.
1 At present cardiac transplantation is the best therapeutic option for this group. However, only 3,500 patients per year are accepted and listed for cardiac transplantation with approximately 2,500 a year receiving a transplant. 2 Of the listed patients, approximately 20% to 30% die while waiting for a donor heart to become available. 3, 4 To prevent the deaths of patients awaiting transplantation, many cardiac transplant centers have developed programs to bridge patients to transplantation by means of mechanical circulatory support devices. The development and clinical application of mechanical circulatory support has closely paralleled the development of cardiac transplantation, and in the patients undergoing bridging to transplantation, these two modalities have become complimentary. The first attempts at bridging to transplantation were made at the Texas Heart Institute. Although the feasibility of such an approach was demonstrated, none of the patients were long-term survivors. 5 The first successful bridge to cardiac transplantation with a mechanical device was performed by Reemtsma and colleagues 6 in 1978, who successfully supported patients with intraaortic balloon pumps before transplantation. Pennington and coworkers 7 supported two patients with an extracorporeal membrane oxygenation system before transplantation, but neither was a long-term survivor. In 1984 and early 1985, Hill, 8Starnes, 9 Copeland, 10 and their associates performed successful bridging procedures using a pneumatic paracorporeal ventricular assist device (VAD), an implantable electrical left ventricular assist system (LVAS), and a Symbion-Jarvik 7 pneumatic total artificial heart (TAH) (Symbion Inc., Salt Lake City, Utah). The present report reviews our experience at St. Louis University of bridging to transplantation with the more sophisticated devices over the past 8 years from May 1985 to May 1993. We have pursued the concept of mechanical support in an attempt to provide the highest salvage rate with the most efficient use of donor hearts.
PATIENTS AND METHODS
This study was done under the auspices of Food and Drug Administration (FDA) Investigational Device Exemptions and with approval of the Institutional Review Board of St. Louis University. Informed consent was obtained from all patients or their families before device insertion.
Patient selection was limited to potential or listed transplant candidates who met the hemodynamic criteria for the specific device to be used. Hemodynamic indications for implantation of the three devices used in this study were similar and included a pulmonary capillary wedge pressure or right atrial pressure (or both) of more than 18 mm Hg, a cardiac index of less than 2.0 L/m2 per minute, and systemic hypotension with a mean systemic blood pressure of less than 65 mm Hg. These hemodynamics should persist despite conventional therapy with any of the following two: dopamine greater than 10 µg/kg per minute; dobutamine greater than 10 µg/kg per minute; amrinone greater than 10 µg/kg per minute; epinephrine greater than 0.02 µg/kg per minute; and isoproterenol greater than 0.05 µg/kg per minute; equivalent doses of other drugs; or intraaortic balloon pump (IABP) support. Exclusion criteria included renal failure, hepatic failure, respiratory failure, severe blood dyscrasia, or any other major organ dysfunction that would limit survival after cardiac transplantation.
The conduct of the operative procedure for placement of the device was similar for all patients receiving VAD and LVAS. VAD implants were performed with the aid of full cardiopulmonary bypass with normothermia or moderate hypothermia (30° to 32° C). Cardioplegic arrest was not used. Bicaval or single venous–ascending aortic cannulation was used in all patients. After the initiation of cardiopulmonary bypass, the intraatrial septum was palpated to determine whether there was a patent foramen ovale. Cannulation for the right VAD was from the right atrium to the pulmonary artery. For left VADs and LVAS implantation, left ventricular cannulation was preferred. However, several early patients receiving the Thoratec VAD (Thoratec Laboratories Corp., Berkeley, Calif.) had left atrial–aortic cannulation. For patients undergoing TAH implantation, bicaval cannulation with moderate hypothermia (25° to 30° C) was used. Technical descriptions and implantation procedures for the three devices used in this study (Pierce-Donachy Thoratec VAD, Novacor LVAS [Baxter Healthcare Corp., Novacor Division, Oakland, Calif.], and Symbion-Jarvik TAH) have been previously reported. 11-14 After cardiopulmonary bypass was discontinued, heparin was reversed with protamine in all patients. The anticoagulation protocol used has been previously described. 15 The regimen included dextran 25 ml/hr intravenously beginning as soon as postoperative bleeding had ceased. As soon as the patient was able to take oral medications, warfarin was begun to maintain the prothrombin time at 1.5 times control. If the patient was unable to take oral medications 48 hours after operation, heparin was initiated to maintain the activated partial thromboplastin time at 1.5 times control. As soon as target levels of warfarin or heparin were achieved, dextran was stopped. Prophylactic antibiotics were given preoperatively and for a minimum of 3 days after device implantation.
The criterion for designation as a candidate for bridging to transplantation in this series was whether the patient was at some time listed with United Network for Organ Sharing (UNOS) as a candidate for cardiac transplantation. The implantation of a circulatory support device alone was not considered justification for entering a patient on the UNOS list. In fact, virtually all patients were withheld from the list until they had reversal of organ dysfunction and reasonably good nutrition. Although not a prerequisite for listing, the ability to ambulate and exercise was usually achieved before the patient was listed.
Postoperative complications were defined as follows:
Survival was defined as the patient being able to be discharged from the hospital at some time after implantation of the support device.
Data were analyzed with the Statview II Statistical Software package (Brain Power, Inc., Calabasas, Calif.). A 
2 test or Fisher's exact test was used to determine significance for discrete variables. Continuous variables were analyzed by a two-tailed Student's t test. A p value less than 0.05 was considered significant. Variables that were not available in at least 95% of the patients were omitted from analysis to avoid loss of statistical power. Actuarial survival was computed by the method of Kaplan and Meier.
RESULTS
Between May 1985 and January 1993, 44 patients were supported on 45 occasions with VADs, LVASs, or TAHs as bridges to cardiac transplantation. One patient was bridged to transplantation twice. He was initially supported with a Thoratec left VAD and subsequently received a donor heart. When the transplanted heart failed, he was supported with biventricular Thoratec VADs for 6 days until the second successful transplantation was accomplished. The 44 patients were supported with mechanical devices for periods ranging from 4 hours to 440 days. Of the 44 patients receiving devices, 27 underwent cardiac transplantation and 26 of them left the hospital, for a survival among transplant recipients of 96.4%. Seventeen patients never received a transplant. Two of them had cardiac recovery sufficient to allow them to be weaned from VADs and ultimately discharged. Fifteen patients who were denied transplantation because of complications died with the devices in place.
From Table I it is apparent that there were no significant differences between survivors and nonsurvivors in predevice parameters of age, gender, etiology of cardiac failure, or predevice hemodynamics. Only the white blood cell count, platelet count, and experience of the investigators proved to be significantly different between the two groups. A statistically significant difference in survival was measured between the last 24 patients when compared with the first 20 patients. The best survival rates were in patients who required only left ventricular support (Table II). There was no significant difference in survival between patients who received a Thoratec VAD versus patients who received a Novacor device. However, from Table II it is apparent that more patients received Thoratec VADs than Novacor VADs or the TAH. Although several factors accounted for the device selection, including patient size and body habitus, the most important factor was whether there was thought to be a significant degree of right ventricular failure. The Thoratec device was preferred in patients with right heart failure because it could be applied to support either or both ventricles. Although the TAH could also support both ventricles, it required removal of the native heart and was used in only two patients. Patients who required biventricular support did significantly worse (p < 0.009, Table III) than those who required only left ventricular support.
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In 
Table III, the complications encountered during the interval of mechanical support are enumerated. The most common complication was infection, with patient-related infections such as pneumonia and mediastinitis occurring more frequently in nonsurvivors. Renal failure and respiratory failure were also significant predictors of nonsurvival, whereas complications attributable to the device such as mechanical failure, hemolysis, and thromboembolism were not. Postdevice implantation hemodynamics and other pertinent clinical parameters are shown in Table IV. Unlike the predevice implant hemodynamics, postdevice implant hemodynamics were predictive of survival. Likewise, renal failure and prolonged need for parenteral nutrition were more common in nonsurvivors.
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The single death of a patient who underwent heart transplantation occurred in a 56-year-old woman who was supported with a TAH for 440 days after her initial transplanted heart failed. At the time of TAH removal to perform the second transplant, there was frank pus surrounding the TAH despite a previous omental wrap of the TAH and the absence of signs of infection for several weeks before transplantation. The 26 patients who underwent transplantation and were discharged were followed up for periods of 2 to 96 months (mean 35 months), with four late deaths at 3, 6, 14, and 68 months (Table V). The actuarial survival curve of the transplant recipients is compared with the survival curve of a cohort of patients from our hospital who underwent cardiac transplantation without the need for mechanical support during the same time period (Fig. 1). The long-term survival data are similar between the two groups. Of the 28 patients discharged (26 receiving transplants and two with myocardial recovery), 24 are currently alive, 23 in New York Heart Association class I and one in class II. Of the four patients who died, three were in New York Heart Association class I before their deaths. Two died suddenly of suspected arrhythmias, and one died of rejection after an alcoholic binge. The fourth patient died of chronic rejection.
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It is apparent from the preceding results that bridging to cardiac transplantation with circulatory support devices is successful, with survivals much better than those obtained in patients receiving VADs for myocardial recovery. 16 These studies further demonstrate that the use of pulsatile VADs such as the Thoratec and Novacor devices before transplantation can provide early survivals equal to or better than those of patients undergoing transplantation without the need for mechanical support. These results are supported by data from FDA-approved investigations of Thoratec, Novacor and Thermo Cardiosystems VADs (Thermo Cardiosystems, Inc., Woburn, Mass.) in which patients subjected to bridging and subsequent transplantation had outcomes at least as good as those undergoing routine cardiac transplantation. 17, 18 Intense competition for the limited supply of donor hearts continues to increase, making it imperative that we optimize the results in all cardiac transplant recipients, including those who require mechanical support. The hospital survival of greater than 96% in our series is primarily attributable to our insistence on performing transplantation only in patients whose organ dysfunction had been reversed, whose nutritional state was improved, and in most cases who were ambulatory with improved exercise tolerance compared with their preimplantation state. These "rehabilitated" patients were excellent candidates for transplantation by the time they received the donor hearts.
Although proper patient selection is the most important determinant of success in bridging to cardiac transplantation, we have previously reported that preimplantation hemodynamic criteria do not predict the outcome of patients receiving circulatory support. 19 It is apparent that the only predevice parameters predictive of survival in this study were platelet count, white blood cell count, and experience. Although the platelet counts in nonsurvivors were significantly lower than those of survivors, they would normally be considered adequate for patients who were about to undergo cardiopulmonary bypass and major cardiac procedures. Therefore, this finding is apparently a statistical value without clinical relevance. However, the experience of the team is important as evidenced by the improved survival of the last 24 patients compared with the survival of the first 20 patients. Because all the devices used in this study were strictly controlled by the FDA, patient selection was limited by the study entry and exclusion criteria, which made the population more uniform. However, if clinical results are to improve, other variables with which to predict outcome must be identified. Patient selection criteria continue to evolve in the areas of predicting complications and determining reversibility of major organ dysfunction.
Selection of the appropriate device and cannulation techniques are obviously important considerations. We have previously described the importance of right ventricular failure in patients with postoperative cardiogenic shock. 20 Mild-to-moderate right ventricular failure in the bridge-to-transplant population can usually be managed with drugs, but some patients have right ventricular failure that is refractory to drugs and necessitates biventricular support. If right ventricular function is in question, we prefer to use a device capable of providing biventricular support. We have inserted a left VAD first and used inotropic support for the right ventricle. If the left VAD flow proved inadequate despite elevated right atrial pressure, a right VAD was inserted. Using this plan, we hoped to provide biventricular support only when it was required. From our experience, the need for biventricular support was a negative prognostic indicator, but its importance in the experience of others has been difficult to assess. Because the Novacor and Thermo Cardiosystems devices were designed for left ventricular support only, patient selection for those may be biased toward individuals who have predominant left ventricular dysfunction. However, at the University of Pittsburgh, a group of patients all initially received the Novacor LVAS, regardless of whether they had biventricular or left ventricular failure. Their survival was excellent, although two patients required right ventricular centrifugal pumps because of right ventricular failure. 21 Because the TAH provides only biventricular support, there is incomplete information as to how many of the TAH recipients had severe biventricular failure. While the Thoratec VAD can provide either left or right ventricular support, some Thoratec investigators implant biventricular assist devices in all patients to eliminate the potential problems of progressive right heart failure and ventricular arrhythmias associated with isolated left ventricular support. Although discrepancies among studies make it difficult to evaluate the type of support a particular patient may need, it is apparent that patients who receive biventricular support have a decreased chance of survival. 13, 22, 23 This increased mortality may be related to the severity of the heart failure or to the added complexity of two devices. It is clear that hybrid systems, such as a Thoratec VAD for the left ventricle and a centrifugal VAD for the right ventricle, have not given satisfactory results. 24 Further studies are needed to refine techniques for determining the need for biventricular support.
Infection was the most common complication occurring in 73% of the patients and all three devices. Because the patients would be immunosuppressed after the transplantation the presence of pretransplantation infection could exclude them as reasonable transplant candidates. However, nine patients underwent transplantation (eight successfully) with ongoing device-related infections. Driveline site inflammation was usually controllable after transplantation because the prosthetic material was removed. 25 In our series, the only death of a transplant recipient occurred in a woman with a failed transplant in whom mediastinal infection developed during 14 months of TAH support. She received a second donor heart but died 4 months later of infection, graft rejection, and renal failure. Patient-related infections such as pneumonia and mediastinitis were of greater concern because these infections lingered and often worsened after transplantation. 26 Furthermore, the increased thromboembolic rate caused by infection in patients with mechanical support has been previously described. 27 Although early studies seemed to identify a higher risk of mediastinitis with the TAH, 26 later experiences with shorter waiting periods did not identify mediastinitis as a complication. 28 Predevice implantation risk factors for the development of infection need to be evaluated further.
Postimplantation bleeding remains a major concern. Despite the fact that the differences were not statistically significant, 50% of the nonsurvivors and only 21% of survivors had excessive bleeding. Bleeding may have contributed to the development of renal failure, respiratory insufficiency, or infection. Patients with bleeding complications received a larger amount of transfused blood products, which may have led to the development of antibodies and the need for longer periods of support (Fig. 2). Since 1988, when we began using single donor (pheresis) platelets and filtered red blood cells with leukocyte-poor filters to reduce the amount of antigen exposure, no patient has required a pretransplantation crossmatch. We have not had the opportunity to use aprotinin in these patients, although some European groups have found it useful in curtailing postimplantation bleeding. 29
Renal failure necessitating dialysis was a strong predictor of postimplantation mortality. Dialysis was required in only one of the 28 survivors and in 38% (p < 0.001) of the nonsurvivors. Renal failure was especially worrisome because cyclosporine might also adversely affect renal function. When renal dysfunction occurred, it was often the result of events before or during placement of the assist device. In these circumstances, the reversibility of renal dysfunction was often difficult to assess because it was not always reversed by the establishment of adequate perfusion. While patients have survived renal dialysis before and after cardiac transplantation, the survival rate in patients who require dialysis during mechanical circulatory support is low. 30
Hemolysis and mechanical failure did not significantly affect survival. The deposition of thrombus in the devices was virtually equal in survivors and nonsurvivors. However, thromboembolism occurred in only 7% of the survivors but in 32% of the nonsurvivors. The antithrombotic protocol was similar for all patients and all devices. The three devices used in this study used smooth-surfaced sacs constructed of thromboresistant polyurethanes. Despite anticoagulants, there is a persistent incidence of thromboembolic events with these devices. 27, 31, 32 A possible exception to this experience is a series of 58 patients with TAH implants at LaPitie Hospital in Paris, France. The apparent absence of device-related thromboemboli in their series was attributed to the anticoagulation protocol used, 29 suggesting that refinements in the anticoagulation and antiplatelet regimen may compensate for imperfections of the blood-contacting surfaces of the devices. 33
Patient selection, an important determinant of success, occurs at two levels, the selection of which patients should receive mechanical support and the selection of which patients undergoing mechanical support should receive a transplant. Temporary mechanical support can provide a screening period during which candidates with previously ill-defined, potentially prohibitive problems can be clearly identified. If these problems are not resolved, such patients must be rejected as cardiac transplant recipients, allowing better allocation of donor organs. Such a triage policy requires that the patient (when possible) and the family be fully informed before device implantation that transplantation may not be possible. However, because these devices are expensive in terms of costs and resources, it is important to keep the survival of patients receiving support devices as well as donor hearts as high as possible. It is especially important that patients become ambulatory, so that the problems associated with being bedridden, such as atelectasis and muscle wasting, are lessened. Most of our patients were maintained outside the intensive care unit for the majority of their implant period, and it is hoped that in the near future more patients can be supported in an outpatient facility or at home.
The concept of patients leaving the hospital during VAD support has already become reality. Two patients supported with the Novacor LVAS and the standard console were managed in a residence facility. 34 One patient with a Thermo Cardiosystems device has been partially supported out of the hospital with a wearable battery pack that allows greater mobility and more normal activity. Both the Novacor and Thermo Cardiosystems wearable battery pack systems have received FDA approval and are in the beginning stages of clinical trials. However, both of these systems still use an energy cable that traverses the body wall, a potential portal of entry for infection.
Considering the severe shortage of donor hearts, bridging to transplantation with mechanical devices is not likely to lower the number of patients dying on the waiting list. However, these bridging experiences have greatly increased our knowledge of patient/device interactions and will be of great value in planning protocols for permanent, totally implantable systems. Electrical implantable LVASs should be available for clinical trials in the near future. When such devices are widely available, the role of bridging to transplantation with devices will have to be reevaluated.
Appendix: DISCUSSION
Dr. Henry J. Sullivan (Maywood, Ill.). Dr. Pennington and his colleagues obtained excellent results in this difficult group of patients. They achieved 60% survival in their 42 patients. I agree that patients who require mechanical support before transplantation can have an excellent long-term result.
At Loyola University we had experience with 19 patients who received the Jarvik heart. Of those 19 patients, two died and the device was turned off. Seventeen patients underwent transplantation. Early mortality before 1 month consisted of two patients. Three patients died later.
Today, 12 of the 17 patients are alive. The patient who has survived longest is alive after 5 years and doing very well. Our most recent insertion was 2
years ago and this patient is alive and well. In this limited subset of patients, we have been able to achieve a long-term survival that is encouraging.
Dr. Daniel Y. Loisance (Créteil, France). A few patients in this group have been supported mechanically for more than 1 year. We may wonder about the quality of life of these patients while waiting for transplantation. One may expect that the use of portable mechanical assist systems will improve the quality of life of the patient waiting long term. Unfortunately, because of the very strict FDA regulation, Dr. Pennington was not allowed to use the wearable systems promptly. Baxter has made the decision to move to Europe and to start in Europe the clinical implantations of the portable Novacor system.
We were fortunate enough, in Henri-Mondor Hospital, to implant for the first time the wearable Novacor system on March 17, 1993. The quality of the system is obvious in the first postoperative days. Nursing care is made easier by the absence of a console. The rehabilitation process of the patient is also facilitated by the lack of console. Very rapidly, the patient was moving freely inside and outside the hospital. He really enjoyed life. Every morning he asked the nurses a very important question: "Are you sure that the transplantation we are waiting for is going to work as well as the machine I am using today? "
This raises many questions. Among these many questions, there is one which is for us extremely important, and that is the cost issue. How are you solving this cost issue in St. Louis?
Dr. J. Donald Hill (San Francisco, Calif.). I would like to reemphasize the importance of carefully selecting the patients that go on to receive a transplant. It is crucial that one not waste hearts.
I would like to note one parameter as a possible contraindication before doing a device implant. The Thoratec series now has more than 200 bridge-to-transplant cases. Some findings representing contraindications have shown up. One of these is an elevated blood urea nitrogen value. This presumably might be a marker for multiorgan disease. In the past, in this series, we have had other parameters, for example, small body size and left ventricular cannulation, that seemed to be potential markers and later disappeared once we had a larger group of patients and more experience. Thus blood urea nitrogen may be a marker, but I would not call it an absolute contraindication for device implantation.
One of the predictors of survival mentioned by Dr. Pennington was a univentricular device versus a biventricular device. In the Thoratec series this never showed up as a predictor of survival. I was wondering whether or not in your series this reflected the earlier more common use of biventricular pumps now replaced by the more common use of a univentricular pump. Is the explanation perhaps better selection of patients now and more experience now?
Last, I would like to address the issue of carefully selecting the patients who undergo transplantation. Sometimes controversial ethical issues arise and there is a lot of pressure to proceed to transplantation despite minor or major center-based contraindications. Have you experienced this and how do you manage it?
Dr. Christian Cabrol (Paris, France). During the same period we supported 139 patients with various VADs, and we observed roughly the same things. From the early beginning, the main problem was to select very strictly the patients to have transplantation to avoid wasting donor hearts. This strict selection is the reason why our transplantation rate after support was less important—about 48%.
I will insist on the interest of the Jarvik heart. We used it in 69 patients, and I think it is a very good device—very potent, very safe, and I am surprised to see the high infection rate that you observed in your series and also in the Pittsburgh series. We have had no problems of that importance. In some situations I think the Jarvik-7 device is the only device that can be placed, for example, in the case of massive destruction of the left ventricle with septal perforation after myocardial infarction. Dr. Pennington, do you agree with this special indication for the TAH?
Dr. Pennington. Thank you, Dr. Sullivan, for your kind comments. I congratulate you on your excellent experience with the Jarvik heart. Perhaps I should deal with those issues and Dr. Cabrol's comments at the same time by saying that we had the Jarvik heart available, but we had difficulty deciding when to use it. One of our problems was that we had too many devices. I would be hesitant to draw conclusions from our small experience of only two patients. Both of them had infections, but one of the patients was a woman supported by the device for 440 days who had several other problems. I am very impressed with both Dr. Cabrol's and Dr. Sullivan's low infection rates, particularly low incidences of mediastinitis, with that device.
Dr. Loisance asked how the cost of these devices is handled? I can tell you that at our institution, even though the devices are under an IDE (investigational device exemption) and FDA regulation, we can charge for the cost of the device, and that's basically what we have done. We have also submitted a charge to the patient for the hospital expenses, and we have collected about 65% of those charges. At least our hospital to this point has been able to tolerate this expense.
I congratulate Dr. Loisance on the implantation of the "wearable" Novacor system. It is wonderful that this potential technique exists. I believe that it is tragic that the system is not available to us, and we look forward to having that device in our own center.
Dr. Hill has pointed out again the need to choose patients for transplantation very carefully. We did not find blood urea nitrogen to be a marker. However, none of the patients with severe renal failure underwent transplantation, so certainly renal failure was important in our patients.
We believe very strongly that patients should not undergo transplantation until they are ambulatory and nutritionally stable and their organ dysfunction has been reversed. Dr. Hill asked an important question about the effect of biventricular failure on outcome. Indeed, it was a significant factor in determining survival, but not in determining whether transplantation was performed. This occurred as a statistical aberration related to our relatively small numbers, because it probably is important in determining both.
We have watched very carefully the blood given to the patients. In the instances in which we had problems with cytotoxic antibodies, we simply waited until the levels came down to an acceptable range and we were able to find a donor with a negative crossmatch that allowed us to carry out successful transplantation.
Footnotes
Read at the Seventy-third Annual Meeting of The American Association for Thoracic Surgery, Chicago, Ill., April 25-28, 1993. 
References
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R. Korfer, A. El-Banayosy, L. Arusoglu, K. Minami, M. M. Korner, L. Kizner, O. Fey, U. Schutt, M. Morshuis, and H. Posival SINGLE-CENTER EXPERIENCE WITH THE THORATEC VENTRICULAR ASSIST DEVICE J. Thorac. Cardiovasc. Surg., March 1, 2000; 119(3): 596 - 600. [Abstract] [Full Text] [PDF]
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T. B. Spanier, J. M. Chen, M. C. Oz, D. M. Stern, E. A. Rose, and A. M. Schmidt TIME-DEPENDENT CELLULAR POPULATION OF TEXTURED-SURFACE LEFT VENTRICULAR ASSIST DEVICES CONTRIBUTES TO THE DEVELOPMENT OF A BIPHASIC SYSTEMIC PROCOAGULANT RESPONSE J. Thorac. Cardiovasc. Surg., September 1, 1999; 118(3): 404 - 413. [Abstract] [Full Text] [PDF]
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R. Korfer, A. El-Banayosy, L. Arusoglu, K. Minami, T. Breymann, D. Seifert, and L. Kizner Temporary pulsatile ventricular assist devices and biventricular assist devices Ann. Thorac. Surg., August 1, 1999; 68(2): 678 - 683. [Abstract] [Full Text] [PDF]
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D. G. Pennington, T. E. Oaks, and D. P. Lohmann Permanent ventricular assist device support versus cardiac transplantation Ann. Thorac. Surg., August 1, 1999; 68(2): 729 - 733. [Abstract] [Full Text] [PDF]
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D. R. Fastenau, D. R. Wagenknecht, and J. A. McIntyre Increased incidence of antiphospholipid antibodies in left ventricular assist system recipients Ann. Thorac. Surg., July 1, 1999; 68(1): 137 - 142. [Abstract] [Full Text] [PDF]
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L. R. McBride, K. S. Naunheim, A. C. Fiore, D. A. Moroney, and M. T. Swartz Clinical experience with 111 thoratec ventricular assist devices Ann. Thorac. Surg., May 1, 1999; 67(5): 1233 - 1238. [Abstract] [Full Text] [PDF]
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E. A. Rose, A. J. Moskowitz, M. Packer, J. A. Sollano, D. L. Williams, A. R. Tierney, D. F. Heitjan, P. Meier, D. D. Ascheim, R. G. Levitan, et al. The REMATCH trial: rationale, design, and end points Ann. Thorac. Surg., March 1, 1999; 67(3): 723 - 730. [Abstract] [Full Text] [PDF]
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